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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Nerve Conduction Velocity Measurement
510(k) Number K921504
Device Name REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS
Applicant
CHALGREN ENTERPRISES, INC.
8021 CARMEL ST.
SUITE B
GILROY,  CA  95020
Applicant Contact RICHARD KAISER
Correspondent
CHALGREN ENTERPRISES, INC.
8021 CARMEL ST.
SUITE B
GILROY,  CA  95020
Correspondent Contact RICHARD KAISER
Regulation Number882.1550
Classification Product Code
JXE  
Date Received03/31/1992
Decision Date 09/11/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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